Safety of operators, environment and product is a major concern in the
pharmaceutical industry. In the design of their One-Pot granulation and drying
plants, Collette (part of GEA Pharma Systems group) has taken this into
account.
Explosion safety
When using solvents during granulation
and drying or certain dry products with a low MIE, there is a risk of
explosion. By eliminating one of the sources necessary to create an explosion,
this risk can be effectively mitigated. The One-Pot system by Collette relies
on an inertization procedure for this end. The oxygen in the bowl is replaced
by nitrogen in a automatic cycle. Oxygen sensors can be provided to ensure the
level is below the explosion limits.
Operator safety
Apart from the containment measures to protect the operator from exposure
to possible harmful active ingredients, the UltimaPro™ is also equipped with
many safety features to eliminate any
risk to the operator while working
with the equipment. Examples are 2 hand trip control for closing the bowl,
safety grids with proximity switched, interlocks in the software, etc.
Risk analysis
Collette is open to assist its
customers with extensive in house experience in establishing a risk based
approach for validation and for HAZOP studies.